(125 days)
The INION BIORESTORE™ implants are bone graft substitutes indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure; packing into bony voids or gaps to fill and/or augment dental intraosseous, oral and craniomaxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including: e.g., periodontal/infrabony defects; alveolar ridge augmentation (sinusotomy, osteotomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; and craniofacial augmentation.
Inion BioRestore™ is an osteoconductive and osteostimulative bioactive bone graft substitute used either separately or in conjunction with autogenous or allograft bone. When implanted, a kinetic modification of the surface occurs, resulting in the formation of a calcium phosphate layer that is essentially similar in composition and structure to the hydroxyapatite found in bone mineral. This apatite layer provides scaffolding onto which the patient's new bone will grow allowing complete repair of the defect. Inion BioRestore™ system consists of different size cylinders, blocks and morsels made of degradable bioactive glass. Inion BioRestore™ implants degrade in vivo in six months based on pre-clinical data. The material is radiopaque. Inion BioRestore™ implants are intended for single use and are provided sterile to the user. They are completely synthetic and non-collagenous.
This document is a 510(k) summary for Inion BioRestore™, a bone graft substitute, and does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.
The 510(k) process is primarily focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed performance studies with acceptance criteria or comparative effectiveness studies.
Therefore, I cannot provide the requested information based on the provided text. The document refers to "performance data and specifications presented" for demonstrating substantial equivalence, but it does not describe what those specific data points or acceptance criteria were. It also mentions "pre-clinical data" for degradation, but not details of the study.
Here's a breakdown of why each point cannot be answered:
- A table of acceptance criteria and the reported device performance: Not present. The document focuses on showing equivalence to predicate devices, not on meeting predefined performance metrics.
- Sample sized used for the test set and the data provenance: Not present. No specific test set or study data is detailed.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/present. No test set requiring expert ground truth is described.
- Adjudication method: Not applicable/present.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This document describes a medical device (bone graft substitute), not an AI-assisted diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
- The type of ground truth used: Not applicable/present.
- The sample size for the training set: Not applicable/present.
- How the ground truth for the training set was established: Not applicable/present.
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.